Final Product Release Testing

Welcome to the homepage for final product lot release testing. All biologicals being released into global pharmaceutical markets require GMP testing of final product packages to demonstrate compliance with regulatory guidelines.

At BioReliance, we offer a wide range of assays and services aimed at ensuring the quality and purity of final biologicals products for the pharmaceutical and biotech industries.

Contact BioReliance and our research team will be happy to assist you in planning your biological production methodology.

More about Final Product Lot Release Testing

Every lot of product produced, both for preclinical and clinical studies, requires a series of tests to ensure active ingredients are free of contaminants according to 21 CFR 211.165 and 21 CFR 610. This testing should be performed separate from final container testing.

Final product should be below acceptable levels for endotoxin and pyrogen levels, free of residual solvents and DNA, and be tested by lot prior to release.

Let the CRO experts at BioReliance, help your team ensure the safety with a carefully planned and executed final product lot release testing program.

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